6421 - CSV Engineer (Laboratory) / Validation Engineer 2
About The Position
Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise Job Overview: We are seeking an experienced CSV Engineer to support the implementation and validation of ELLA and Synergy Neo2 laboratory instruments. The ideal candidate should have hands-on experience supporting GxP laboratory instrument implementations and be comfortable managing validation activities for both technologies in parallel.
Requirements
- Strong CSV experience in a GxP laboratory or regulated life sciences environment
- Prior experience with laboratory instrument implementation and validation
- Experience with ELLA and Synergy Neo2 strongly preferred
- Ability to manage multiple validation activities or technologies concurrently
- Familiarity with IQ/OQ/PQ, CSV lifecycle documentation, risk-based validation, data integrity, and Part 11 expectations
- Strong communication skills and ability to work effectively with cross-functional teams
- Experience supporting ECQ or lab equipment qualification
- Experience in biotech, pharma, plasma, or manufacturing laboratory environments
- Prior experience working in client-facing hybrid/onsite roles
Responsibilities
- Support CSV activities for ELLA and Synergy Neo2 instrument implementation
- Develop, review, and/or execute validation deliverables including validation plans, risk assessments, test protocols, traceability matrices, summary reports, and related documentation
- Partner with laboratory, Quality, IT, and project stakeholders to ensure validation activities are completed on schedule
- Support GxP compliance, data integrity, and 21 CFR Part 11 considerations as applicable
- Manage validation workstreams for both instruments simultaneously
- Identify and escalate risks, gaps, delays, or documentation issues
- Support deviation resolution and documentation updates during protocol execution
Benefits
- Competitive pay plus performance-based incentive programs
- Company-paid Life, Short-Term, and Long-Term Disability Insurance.
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Supplemental Life, Hospital, Critical Illness and Legal Insurance
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- As Needed Sick Time
- Tuition Reimbursement
- Team Social Activities (We have fun!)
- Employee Recognition
- Employee Referral Program
- Paid Parental Leave and Bereavement
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
